This Funding Opportunity Announcement (FOA) invites grant
applications for the Research Specialist Award (R50) in any area of NCI-funded
cancer research. This FOA is specifically for core/shared resource/central
scientific support scientists.

The Research Specialist Award is designed to encourage the
development of stable research career opportunities for exceptional
scientists who want to continue to pursue research within the context of an existing
NCI-funded basic, translational, clinical or population science cancer
research program, but not serve as independent investigators. These
scientists, such as researchers within a core/shared resource/central
scientific support, are vital to sustaining the biomedical research
enterprise. The Research Specialist Award is intended to provide salary
support and sufficient autonomy so that individuals are not solely dependent
on NCI grants held by others for career continuity.

Key Dates

Posted Date

November 4, 2016

Open Date (Earliest Submission Date)

January 2, 2017

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

February 2, 2017, by 5:00 PM local time of applicant
organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May/June 2017

Advisory Council Review

August 2017

Earliest Start Date

September 2017

Expiration Date

February 3, 2017

Due Dates for E.O. 12372

Not Applicable

Required
Application Instructions

It is critical that applicants follow the Research (R) Instructions
in the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all requirements (both
in the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

This Funding Opportunity Announcement (FOA) invites grant
applications for the Research Specialist Award (R50) in any area of NCI-funded cancer
research.

The Research Specialist Award is designed to encourage the
development of stable research career opportunities for exceptional scientists
who want to continue to support research within the context of an existing NCI-funded
basic, translational, clinical or population science cancer research program,
but not serve as independent investigators. These non-tenure track scientists,
i.e. researchers within a core/shared resource/central scientific support, are
vital to sustaining the biomedical research enterprise.

Background

The Research Specialist Award is intended to provide salary
support and sufficient autonomy so that individuals are not solely dependent on
NCI-funded grants held by others for cancer research career continuity. Over
the past decade, there has been a major expansion in the scope of approaches,
technologies and expertise required to effectively address any research question.
A typical research activity includes molecular, genomic, phenotypic, and
functional characterizations, each of which entails sophisticated technologies
and understanding (e.g., deep sequencing, bioinformatics, imaging, flow
cytometry, animal modeling, etc.). Accompanying the increases in the number of
required approaches is the growing need for exceptional scientists with
extensive research experience in each of those areas who provide continuity,
stability and detailed scientific knowledge beyond that of a technician or a
trainee. There is already a clustering of individual small research groups
around central cores that specialize in different expertise (e.g., nuclear magnetic
resonance [NMR], mass spectrometry [MS], sequencing, fluorescence-activated
cell sorting [FACS], biochemistry, animal models, etc.), such that many
experiments are performed, at least in part, through such cores. In addition,
with the generation of large datasets (“big data”) that are publicly available,
there is a growing need for IT experts within many research programs or
departments that previously did not rely on these skill sets. Data
scientists (e.g., informaticians, statisticians, epidemiologists, behavioral
scientists, and population scientists) are found primarily in computational
biology groups or in data-rich big science groups. The need for such
individuals is rapidly expanding to many other types of research groups.

There has been a continuing shift in the way research is
organized, with increased reliance on a cadre of Research Specialists in
laboratories, cores, and other scientific support facilities. Extramural
institutions have begun to address the need for such scientists by providing
staff support for cores that serve multiple research programs. Moreover,
individual research programs have created Research Specialist positions using
their grant support. However, neither of these positions currently provides the
individual with either the recognition or independent funding mechanism that
will attract and maintain the best scientists. All of these examples and many
others highlight the need to create a career path for highly trained
researchers who will play an increasingly important role in advancing
biomedical research.

Scope of this FOA

The Research Specialist Award (Core-based Scientist) is
intended to provide salary support for a sustained period of time and encourage
the development of a stable career for exceptional researchers who want to
continue to support cancer research within the context of a core/shared
resource/central scientific support. These scientists, namely researchers
within a core/shared resource/central scientific support,, are vital to
sustaining the biomedical research enterprise. The award is intended for
research-oriented investigators with significant, relevant experience, who have
shown clear evidence of productivity and research excellence in the field of
their training, and who would like to support a particular research activity
(e.g., core/shared resource/central scientific support), with the goal of
making significant contributions to behavioral, biomedical (basic or clinical),
computational, bioimaging or bioengineering research that is relevant to the
NCI mission. The proposed new research support is intended to provide salaries
and sufficient autonomy so that individuals are not solely dependent on NCI-funded
grants held by others for career continuity. Research Specialists would
have the option, with prior NCI approval, to move to other research programs or
institutions while maintaining funding from this award (e.g., if the Unit
Director's core is closed, if the institution closes a core, etc.).

Unit Director of the core/shared resource/central scientific
support

The Unit Director must be a NCI-funded Program Director/Principal
Investigator (PD/PI) with an established working relationship with the Research
Specialist. The Research Specialist must, at the time of the R50
application submission, be supported by the Unit Director's NCI-funded
grant(s). The Unit Director, together with the Research Specialist, is
responsible for planning, directing, monitoring, and executing NCI-funded research
activities currently being conducted within the core/shared resource/central
scientific support. It is anticipated that only exceptional scientists who want
to continue to support an existing NCI-funded departmental or institutional core/shared
resource/central scientific support will be competitive for this award.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are not allowed.

Required
Registrations

Applicant
Organizations

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons. If the PD/PI is also the organizational Signing Official,
they must have two distinct eRA Commons accounts, one for each role. Obtaining
an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Multiple PD/PIs are not permitted for the Research
Specialist Award. Only single-PD/PI Research Specialist applications are
allowed. Applications with multiple-PD/PI Research Specialists will not be
accepted.

Additional
Eligibility Requirements for Research Specialist:

The Research Specialist must have an advanced degree (e.g.
Masters, PhD, DVM, DDS or MD) in an area of biomedical science or biomedical
engineering and have demonstrated research accomplishments in their primary
discipline.

The Research Specialist must have a full-time, non-tenure track position
at the academic or research institution and be supported by at least 6-person
month effort on NCI-funded research at the time of submission.

The Research Specialist will be required to commit a minimum of 6-person
month effort on NCI-funded research in order to receive the R50 award. The
Research Specialist may engage in other duties as part of the remaining 6-person
month effort not covered by this award.

The Research Specialist must have demonstrated professional
accomplishments consonant with his or her career status, and should have
demonstrated cancer research experience in the areas of behavioral, biomedical
(basic or clinical), computational or bioengineering research that is relevant
to the NCI mission.

The Research Specialist must have been contributing to the Unit
Director's NCI-funded research activities currently being conducted within the core/shared
resource/central scientific support for at least the last 2 years (since
February 2015).

The Research Specialist must not have held or applied for
independent investigator grant support (e.g. including but not limited to: R00,
R01, R03, R21, R43, R44) within the past 5 years.

Additional
Eligibility Requirements for the Unit Director:

The Unit Director must be a NCI-funded Principal Investigator
(PD/PI) with NCI funding support through September 2019, excluding no cost
extensions or supplements.

The Unit Director must be currently supporting the Research
Specialist with his/her NCI grant(s) and be committed to both the Research
Specialist and the Research Specialist’s research.

Only 1 Unit Director may be designated on the application.
Applications that list more than 1 Unit Director, or in which the Unit Director
does not indicate eligible NCI grant support will not be reviewed.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping
applications under review at the same time. This means that the NIH will
not accept:

A new (A0) application that is submitted before issuance of the
summary statement from the review of an overlapping new (A0) or resubmission
(A1) application.

A resubmission (A1) application that is submitted before issuance
of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another
application pending appeal of initial peer review (see NOT-OD-11-101).

Level of Effort

The Research Specialist will be required to commit a minimum
of 6-person month effort on NCI-funded research in order to receive and retain
the R50 award. The Research Specialist may engage in other duties as part of
the remaining 6-person month of effort not covered by this award.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Buttons to access the online ASSIST system or to download
application forms are available in Part
1 of this FOA. See your administrative office for instructions if you plan
to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Research (R) Instructions
in the SF424
(R&R) Application Guide, including Supplemental
Grant Application Instructions except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in
the SF424 (R&R) Application Guide and should be used for preparing an
application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide
must be followed.

The Research Specialist should be listed as the PD/PI of this
application.

The Unit Director should be listed in Key Personnel as an Other
Significant Contributor.

Both the Research Specialist and the Unit Director must include a
Biosketch. If either Biosketch is missing, the application will not be
reviewed.

R&R Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Specific
Aims: Do not use. Specific Aims are not required.

Research
Strategy: Upload the Research Strategy as a single
attachment and organize the Research Strategy using the instructions provided
below. Start each section of the document with the appropriate section heading:

1)
Research Program(s) engaging the Research Specialist's activity/effort: Describe the NCI-funded research program(s) supported by the Unit Director’s core/shared
resource/central scientific support which the Research Specialist currently
supports. Explain the spectrum and types of research program(s) to which the
Research Specialist currently contributes and is likely to contribute in the
future.

2) Role
of the Research Specialist in Research Program(s): Describe
the particular activity of the Research Specialist in the NCI-funded research
program(s) described above and the need for the Research Specialist to ensure
success of the program(s). This section should explain how the Research
Specialist’s qualifications, experience, productivity, accomplishments and
training are critical to achieving the research goals of the NCI-funded
research supported by the core/shared resource/central scientific support.
Describe how the Research Specialist has a history of making seminal
contributions to new methodologies, approaches, assays, or other research
innovations that helped advance the NCI-funded research goals of the core/shared
resource/central scientific support users. Describe the Research Specialist’s
plans for meeting the objectives of the various NCI-funded research program(s)
over the next 5 years. This plan should also describe the Research
Specialist's career goals.

Letters
of Support: Institutions must include Letters of Support for
the applicant who is applying for the Research Specialist Award. Applications
that are missing Letters of Support will not be reviewed.

Two types
of Letters of Support are required for this application:

1) A letter of support from the Unit Director, which should detail
the following:

a) The Unit Director must document a strong,
well-established cancer research program related to the Research Specialist's area
of expertise, including a high-quality research environment with key faculty
members and other investigators capable of productive collaboration with the
Research Specialist.

b) Include a statement attesting to the Research
Specialist's current level of effort (at the time of submission) on the Unit
Director's NCI-funded research and cite the NCI-funded grant number(s). In
addition,cite all other NCI-funded PD/PI names and grant(s) numbers who contribute
to the support of the Research Specialist within the core/shared resource/central
scientific support (the Research Specialist must commit at least 6-person month
effort to NCI-funded research).

c) Include a statement describing the length of
time that the Unit Director and the Research Specialist have been working
together or how long the Research Specialist has been supporting the Unit
Director’s core/shared resource/central scientific support.

d) Provide assurance about how the Research
Specialist is an integral part of the institution’s cancer research program and
their commitment to the Research Specialist career track now and in the future.

e) The Unit Director should document that they
have sufficient NCI-funded research support (at least through September 2019
excluding no cost extensions or supplements) to cover the costs of the proposed
research project in excess of the allowable costs of this award.

2) At least three letters of recommendation from PDs/PIs of
other research programs who can attest to the Research Specialist's
qualifications and contributions to cancer research by supporting the function
of the Unit Director’s core/shared resource/central scientific support.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
Application Guide, with the following modification:

Generally, Resource Sharing Plans are expected, but they are not
applicable for this FOA.

Appendix:

Do
not use the Appendix to circumvent page limits. Follow all instructions for the
Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions
for completing PHS Inclusion Enrollment Report as described in the SF424
(R&R) Application Guide.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide
must be followed.

3. Unique Entity Identifier
and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the
requirement for obtaining a unique entity identifier and for completing and
maintaining active registrations in System for Award Management (SAM), NATO
Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and
Grants.gov

4. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to
submit applications before the due date to ensure they have time to make any
application corrections that might be necessary for successful submission. When
a submission date falls on a weekend or Federal
holiday, the application deadline is automatically extended to the next
business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission process
by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the application
due date and time. If a Changed/Corrected application is submitted after the
deadline, the application will be considered late. Applications that miss the
due date and time are subjected to the NIH Policy on Late Application
Submission.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically. If you encounter a system issue beyond your control that
threatens your ability to complete the submission process on-time, you must
follow the Guidelines
for Applicants Experiencing System Issues. For assistance with application
submission, contact the Application Submission Contacts in Section VII.

Important
reminders:

All PD(s)/PI(s) must include their eRA Commons ID in
the Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH. See Section III of this FOA for information on
registration requirements.

The applicant organization must ensure that the DUNS
number it provides on the application is the same number used in the
organization’s profile in the eRA Commons and for the System for Award Management.
Additional information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness and compliance with application instructions by the Center for
Scientific Review, NIH. Applications that are incomplete or non-compliant will
not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in the policy.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

For
this particular announcement, note the following:

Applicants are expected to provide a broad overview that is
consistent with the Research Specialist’s level of research development and
objectives. This description should not be as detailed as an application
for an investigator-initiated research grant (e.g., R01), but should explain
the spectrum and types of research programs utilizing the core/shared resource/central
scientific support to which the Research Specialist currently contributes and
is likely to contribute in the future.

Research Specialist Award applications do not require
preliminary data, specific aims, and/or a detailed research plan.

Accordingly,
reviewers will consider the following:

1) Personal accomplishments of the Research Specialist, both
individually and within the context of the nominating research core/shared
resource/central scientific support;

3) The scope of the particular activity(s) being proposed
and the suitability of the Research Specialist;

4) The importance of the Research Specialist, as well as the
commitment of the Unit Director, to the proper and successful functioning of
the core/shared resource/central scientific support;

5) The letter of support from the Unit Director and letters
of recommendation from other investigators; and

6) The contributions of the Research Specialist to the
nominating core/shared resource/central scientific support to date.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project, to which the research
specialist contributes by supporting the core/shared resource/central
scientific support, to exert a sustained, powerful influence on the research
field(s) involved, in consideration of the following review criteria and
additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a particular activity that by its
nature is not innovative may be essential to advance a field.

Significance

Does the Research Specialist support research that
addresses an important problem or a critical barrier to progress in the field?
Is there a strong scientific premise for the particular activity being
described? If the goals of the Unit Director's core/shared resource/central
scientific support are achieved, how will scientific knowledge, technical
capability, and/or clinical practice be improved? How will successful
completion of the goals of the core/shared resource/central scientific support
change the concepts, methods, technologies, treatments, services, or
preventative interventions that drive this field?

Specific
to this FOA: Will the proposed research area/programs
benefit in terms of productivity and contributions from the Research
Specialist's participation? Is there a satisfactory and appropriate
relationship of the NCI-funded research supported by the core to the Research
Specialist's goals and experience? How solid is the foundation of the proposed
role of the Unit Director’s core?

Investigator(s)

Is the Research Specialist well suited to supporting
the Unit Director's core/shared resource/central scientific support? Does the
Research Specialist have the appropriate experience and training? Has the
Research Specialist demonstrated an ongoing record of accomplishments that have
advanced their field(s)? If the Research Specialist supports a
collaborative project do the investigators have complementary and integrated expertise;
are their leadership approach, governance and organizational structure
appropriate for the project?

Specific
to this FOA: Are the Research Specialist’s level of
training, experience, and competence commensurate with the purposes of the
award? Has the applicant demonstrated the importance of the Research
Specialist role in the Unit Director’s core/shared resource/central scientific
support? Has the applicant been critical for and contributed to the successes
of the Unit Director’s core/central scientific support? Does the application
indicate appropriate commitment of time and effort for the proposed work? Are
the career goals of the Research Specialist appropriate for the R50? Do the
letters of reference address the Research Specialist’s potential for continued
success/productivity?

Innovation

Do the particular activities of the Research
Specialist challenge and seek to shift current research or clinical practice
paradigms by utilizing novel theoretical concepts, approaches or methodologies,
instrumentation, or interventions? Are the Research Specialist's concepts,
approaches or methodologies, instrumentation, or interventions novel to one
field of research or novel in a broad sense?

Specific
to this FOA: In what ways has the Research Specialist
contributed to the innovation of the Unit Director's core/shared resource/central
scientific support?

Approach

Are the overall strategy, methodology, and analyses
appropriate to the particular activity of the applicant goals of the core/shared
resource/central scientific support? Has the Research Specialist presented
strategies to ensure a robust and unbiased approach, as appropriate for the
work being described? Are potential problems, alternative strategies, and
benchmarks for success presented? If the project is in the early stages of
development, will the applicant be able to establish feasibility and will
particularly risky aspects be managed? Does the Research Specialist
present adequate plans to address relevant biological variables, such as sex,
for studies in vertebrate animals or human subjects?

Specific
to this FOA: Is it likely that the Research Specialist
will develop new research capabilities and/or approaches that will allow
progress in the Unit Director's core/shared resource/central scientific support?
How will the Research Specialist contribute to important and reliable data to
the Unit Director's core/shared resource/central scientific support?

Environment

Will the scientific environment in
which the work will be done contribute to the probability of success? Are the
institutional support, equipment and other physical resources available to the
investigators adequate for the project proposed? Will the project benefit from
unique features of the scientific environment, subject populations, or
collaborative arrangements?

Specific
to this FOA: Evaluate the level of accomplishment and
commitment of the Unit Director. Does the Unit Director document that they have
sufficient NCI-funded research or resource support to cover the costs of the Research
Specialist's research or resource provision activities? Is there clear
commitment from the Unit Director to ensure that a minimum of 6-person month effort
will be devoted directly to NCI-funded research?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

Generally not applicable.
Reviewers should bring any concerns to the attention of the Scientific Review
Officer.

Inclusion of Women, Minorities,
and Children

Generally not applicable. Reviewers should bring any
concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any
concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable.
Reviewers should bring any concerns to the attention of the Scientific Review
Officer.

Resubmissions

For Resubmissions, the committee
will evaluate the application as now presented, taking into consideration the
responses to comments from the previous scientific review group and changes
made to the project.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the
information provided in this section of the application, including 1) the
Select Agent(s) to be used in the proposed research, 2) the registration status
of all entities where Select Agent(s) will be used, 3) the procedures that will
be used to monitor possession use and transfer of Select Agent(s), and 4) plans
for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Not Applicable

Authentication of Key Biological
and/or Chemical Resources:

For projects involving key biological and/or chemical
resources, reviewers will comment on the brief plans proposed for identifying
and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the
budget and the requested period of support are fully justified and reasonable
in relation to the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by National
Cancer Institute (NCI), in accordance with NIH peer review
policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications submitted
in response to this FOA. Following initial peer review, recommended applications
will receive a second level of review by the National Cancer Advisory Board. The
following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons. Refer to Part 1 for dates for peer review, advisory council
review, and earliest start date.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications. The
NoA signed by the grants management officer is the authorizing document and
will be sent via email to the grantee’s business official.

1) Research Specialist Awards would support the salaries of
individuals in various types of positions, including but not limited to
research program scientists, data scientists, and core directors.

2) The requested salary support for the Research Specialist
should be commensurate with their current (at the time of submission)
NCI-funded level of effort on NCI research grants. Research Specialists would
be expected to spend the at least 6-person months of their effort on NCI-funded
research.

3) The award would allow application for travel funds, but not
cover research expenses. Research expenses must be covered from other
sources such as separate R01, P01, or P50 grants awarded to the Institution.

4) Funds freed up through the R50 will be restricted from
any other use without NCI prior approval. The competitive renewal of the Unit
Director’s grant will be restricted from including the Research Specialist
position and associated personnel funds in their competitive renewal budget.

5) Research Specialists would have the option, with prior
NCI approval, to move to other research programs or institutions (e.g. if the
Unit Director's laboratory is closed, if the institution closes a core,
etc.).

6) Research Specialists Awards would be for 5 years and
could be renewed. Awards will not be provided the authority to extend the final
budget period of the previously approved project period beyond the original
expiration date shown in the Notice of Award, as outlined in the NIH Standard
Award Terms and Conditions. All extensions, including the first extension,
will require NIH prior approval.

7) If the Research Specialist applies for future NCI research
support, the Research Specialist Award will be taken into consideration in
making funding decisions if ESI/NI status is claimed.

8) The R50 must be relinquished if any other
independent grant support is obtained by the Research Specialist.

9) Support of the R50 (including support recommended
for future years) will be contingent upon the Research Specialist’s research
being supported under an NCI funded research grant(s).

Recipients of federal financial
assistance (FFA) from HHS must administer their programs in compliance with
federal civil rights law. This means that recipients of HHS funds must ensure
equal access to their programs without regard to a person’s race, color,
national origin, disability, age and, in some circumstances, sex and religion.
This includes ensuring your programs are accessible to persons with limited
English proficiency. HHS recognizes that research projects are often limited
in scope for many reasons that are nondiscriminatory, such as the principal
investigator’s scientific interest, funding limitations, recruitment requirements,
and other considerations. Thus, criteria in research protocols that target or
exclude certain populations are warranted where nondiscriminatory
justifications establish that such criteria are appropriate with respect to the
health or safety of the subjects, the scientific study design, or the purpose
of the research.

For additional guidance regarding how the provisions apply
to NIH grant programs, please contact the Scientific/Research Contact that is
identified in Section VII under Agency Contacts of this FOA. HHS provides
general guidance to recipients of FFA on meeting their legal obligation to take
reasonable steps to provide meaningful access to their programs by persons with
limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html.
The HHS Office for Civil Rights also provides guidance on complying with civil
rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html;
and http://www.hhs.gov/ocr/civilrights/understanding/index.html.
Recipients of FFA also have specific legal obligations for serving qualified
individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
Please contact the HHS Office for Civil Rights for more information about
obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS
Departmental goal to ensure access to quality, culturally competent care,
including long-term services and supports, for vulnerable populations. For
further guidance on providing culturally and linguistically appropriate
services, recipients should review the National Standards for Culturally and
Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in
Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal
Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal
Awardee Performance and Integrity Information System (FAPIIS) requirements.
FAPIIS requires Federal award making officials to review and consider
information about an applicant in the designated integrity and performance
system (currently FAPIIS) prior to making an award. An applicant, at its
option, may review information in the designated integrity and performance
systems accessible through FAPIIS and comment on any information about itself
that a Federal agency previously entered and is currently in FAPIIS. The
Federal awarding agency will consider any comments by the applicant, in
addition to other information in FAPIIS, in making a judgement about the
applicant’s integrity, business ethics, and record of performance under Federal
awards when completing the review of risk posed by applicants as described in
45 CFR Part 75.205 “Federal awarding agency review of risk posed by
applicants.” This provision will apply to all NIH grants and cooperative
agreements except fellowships.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

In accordance with the regulatory requirements provided at
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have
currently active Federal grants, cooperative agreements, and procurement
contracts from all Federal awarding agencies with a cumulative total value
greater than $10,000,000 for any period of time during the period of
performance of a Federal award, must report and maintain the currency of
information reported in the System for Award Management (SAM) about civil,
criminal, and administrative proceedings in connection with the award or
performance of a Federal award that reached final disposition within the most
recent five-year period. The recipient must also make semiannual
disclosures regarding such proceedings. Proceedings information will be
made publicly available in the designated integrity and performance system
(currently FAPIIS). This is a statutory requirement under section 872 of
Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010
of Public Law 111-212, all information posted in the designated integrity and
performance system on or after April 15, 2011, except past performance reviews
required for Federal procurement contracts, will be publicly available. Full
reporting requirements and procedures are found in Appendix XII to 45 CFR Part
75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.